Cardiovascular Risk Markers in Veterans With Post Traumatic Stress Disorder (CVMarkers)

This study has been terminated.
(The funding agency, DoD, determined that the study could not meet its enrollment numbers by the end of the grant)
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier:
NCT01650220
First received: June 20, 2012
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

This is an observational study designed to determine whether veterans with PTSD have a higher risk of heart disease than those without PTSD. Cardiovascular risk will be assessed by interview and review of medical records, carotid artery ultrasound, and blood tests measuring markers of inflammation. Study participation is approximately 6 months. The eligible study population is veterans of Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF), age 28 through 38 years.


Condition
Cardiovascular Disease
Post Traumatic Stress Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cardiovascular Risk Markers in Veterans With PTSD

Resource links provided by NLM:


Further study details as provided by INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium:

Primary Outcome Measures:
  • Recruitment methods feasibility [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Comparison of the number of participants per month recruited from medical providers (with/without PTSD) vs. response to recruitment fliers (with/without PTSD) in the first 12 months of the study. Selection bias to be determined by looking at differences in age and co-morbid illnesses.

  • Completion of structured diagnostic interview within 2hrs. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Completion of Clinician Assessed PTSD Scale (CAPS), Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), Patient Health Questionnaire-9 (PHQ-9), Pittsburgh Sleep Quality Index (PSQI), INTRuST Uniformed Data Set, and Family History of heart disease, within 2hrs.

  • Ability to schedule Carotid Intima-Media Thickness (CIMT) ultrasound in the Vascular Lab at VA San Diego Healthcare Systems, within 4 months of enrollment [ Time Frame: 18months ] [ Designated as safety issue: No ]
    Determining whether the Vascular Lab has the capacity for a larger clinical study will be informative in planning larger prospective studies.

  • Time from CIMT completion to completion of clinical read. [ Time Frame: 18months ] [ Designated as safety issue: No ]
    Rate of clinical read will help in determining adequate staffing requirements for a larger study.

  • Completion of serum lab measurements. [ Time Frame: 18months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Carotid Intimal Medial Thickness (CIMT) measurement [ Time Frame: Within 4 months of subject recruitment ] [ Designated as safety issue: No ]
    CIMT thickness will be measured by carotid ultrasound

  • Cardiovascular Disease Biomarkers [ Time Frame: Within 6 months of subject recruitment ] [ Designated as safety issue: No ]
    Serum C-reactive protein and interleukin-6 will be measured


Biospecimen Retention:   Samples With DNA

For the assessment of CVD risk, high-sensitivity CRP (hs-CRP) measurements will be used. Standard assays detect 1,000 fold increases in CRP in response to infection or inflammation; these high levels cannot be used to stratify with respect to CVD risk. Hs-CRP, however, measurement can detect CRP levels as low as 0.5 mg/L. Though mainly used for research purposes, high-sensitivity IL-6 assays are also able to discriminate IL-6 levels within the normal range for CVD risk stratification. Both CRP and IL-6 levels will be analyzed as continuous quantitative traits.

Though no DNA analysis is planned for this study, subjects are asked if they are willing to have their samples banked for future research.


Enrollment: 13
Study Start Date: April 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Veterans with a history of PTSD
Veterans without a history of PTSD

  Eligibility

Ages Eligible for Study:   28 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

OIF and OEF veterans within the VASDHS, who are between 28 and 38 years of age inclusively

Criteria

Inclusion Criteria:

  • OEF/OIF veterans at the VASDHS
  • Between 28 and 38 years of age
  • Willing to complete structured diagnostic interview for PTSD, CIMT ultrasound and blood test
  • Willing to have a review of their medical records
  • Able to give informed consent
  • Have a negative urine pregnancy test, if a woman of child-bearing age

Exclusion Criteria:

  • Do not meet inclusion criteria
  • History of schizophrenia, other neurocognitive illness (including severe TBI by INTRuST criteria)) or active alcohol and/or drug abuse determined by chart review, interview or AUDIT-C score
  • Inability to complete study tests within 18 months of study start
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650220

Locations
United States, California
VASDHS
San Diego, California, United States, 92161
Sponsors and Collaborators
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Vibha Bhatnagar, MD University of California, San Diego
  More Information

No publications provided

Responsible Party: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
ClinicalTrials.gov Identifier: NCT01650220     History of Changes
Other Study ID Numbers: INTRuST-CV Markers
Study First Received: June 20, 2012
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014